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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceUltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage 1944/1948, Ten
Generic NameDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP960030
Supplement NumberS084
Date Received05/06/2026
Decision Date06/11/2026
Product Code NVN 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedYes
Approval Order Statement  
approval for a predetermined change control plan (PCCP) that encompasses a the installation and validation of a semi-automated device packaging line and a cleanroom expansion of current ISO 7 cleanrooms into recently converted ISO 7 cleanrooms at Abbott’s bradycardia lead manufacturing site. The supplement also requested approval for conversion of some ISO 8 cleanrooms into ISO 7 cleanrooms, which will subsequently be expanded as part of the PCCP.
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